Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Findings from a new study on the causes of gastroesophageal reflux disease (GERD) may lead to new way of treating the condition. According to a team of researchers from the University of Texas Southwestern Medical Center, GERD, which causes painful chest pain and heartburn, may be caused by immune system cells causing inflammation. The study showed that gastroesophageal reflux in rats causes tissue in the esophagus to release immune chemicals called cytokines. Those cytokines attract inflammatory cells that cause the uncomfortable symptoms associated with heartburn and GERD.

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Salix Pharmaceuticals plans to increase its sales force by 60 percent in anticipation of approval by the Food and Drug Administration (FDA) for the drug maker’s new treatment for gastroparesis. The FDA recently accepted the complete response from the Morrisville, North Carolina-based pharmaceutical company for its orally disintegrating tablet (ORT), a form of metoclopramide called Metozolv, and has granted a Prescription Drug User Fee Act (PDUFA) for September 11, 2009. A PDUFA authorizes the FDA to collect fees from companies that produce certain human drug and biological products.

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The Food and Drug Administration (FDA) has accepted the complete response from Salix Pharmaceuticals for its orally disintegrating tablet (ORT) form of metoclopramide called Metozolv, and says it has granted a Prescription Drug User Fee Act (PDUFA), which authorizes the FDA to collect fees from companies that produce certain human drug and biological products, for September 11, 2009. Salix is seeking approval for its drug in the treatment of short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal refulx (GERD or heartburn) who fail to respond to conventional therapy, and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (delayed emptying of the stomach).

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Heartburn and gastroesophageal reflux (GER) occur when the lower esophageal sphincter opens spontaneously or does not close properly, allowing stomach contents to rise up into the esophagus. GER is also called acid reflux or acid regurgitation, and when it occurs, food or fluid can be tasted in the back of the mouth and may cause a burning sensation in the chest or throat.

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